Interpretation of the 2022 Guidelines for Prostate Cancer Screening, Early Diagnosis and Treatment in China (Part 2)

*Only for medical professionals to read and refer to.
Detailed interpretation of Chinese prostate cancer screening method recommendations, screening organization procedures and follow-up recommendations
.

With the improvement of China's economic level, the improvement of people's living standards and the prolongation of life expectancy, the incidence of prostate cancer in China has shown a significant upward trend, and it is gradually becoming an important disease affecting the health of middle-aged and elderly men in China
.

In 2015, the overall incidence of prostate cancer in China was 10.
23/100,000 people, and the mortality rate was 4.
36/100,000 people
.

According to the statistics and forecast of the International Agency for Research on Cancer of the World Health Organization, in 2020, the incidence of prostate cancer in China will be about 15.
6/100,000, with over 110,000 new cases and over 50,000 deaths [1]
.

Unlike other cancers, prostate cancer patients hardly have any symptoms in the early stage, which makes prostate cancer easy to be overlooked and public awareness of early screening is weak
.

In China, more than 2/3 of prostate cancer patients are in the middle or locally advanced stage when they are first diagnosed, and they miss the best opportunity for treatment.
"Early screening, early diagnosis and early treatment" is an effective method to improve the 5-year survival rate of patients.
One of [2]
.

Screening of high-risk groups of prostate cancer and early diagnosis and treatment of patients are crucial to improving the cure rate of prostate cancer.
In order to promote the homogeneity and standardization of prostate cancer screening in China and improve the effect of prostate cancer screening, domestic experts and scholars The "Guidelines for Prostate Cancer Screening, Early Diagnosis and Treatment in China (2022, Beijing)" (hereinafter referred to as the "Guidelines") have been formulated [3]
.

The second half of the "Guidelines" will be explained in detail below, that is, recommendations on screening methods, screening organization procedures, and follow-up recommendations for prostate cancer in China
.

Prostate-specific antigen (PSA) and free prostate-specific antigen (f-PSA) are significantly elevated, which can be used as a reference for the early diagnosis of prostate cancer
.

In the past few years, due to the advantages of strong specificity, high sensitivity and accurate detection, PSA screening can be used as a population screening index [4]
.

The "Guide" recommends PSA as the first choice for prostate cancer screening [3]
.

The US PLCO trial set the cutoff value of PSA detection level at 4.
0ng/mL[5], and a Meta-analysis evaluated the value of PSA in the early screening of prostate cancer in the Chinese population, using 4.
0ng/mL as the cutoff point to detect prostate cancer The sensitivity, specificity and area under the curve of the integrated receiver operating characteristic curve were 91%, 41% and 0.
91, respectively [6]
.

Based on the above evidence, the "Guideline" recommends that the PSA cut-off value be set at 4.
0 ng/mL in prostate cancer screening in China[3]
.

Regarding other screening methods, the "Clinical Application of Prostate-Specific Antigen Detection for Prostate Cancer" issued by the National Health and Family Planning Commission in 2015 pointed out that when the serum PSA concentration is ≥4.
0μg/L, a digital rectal examination (DRE) should be performed.
If DRE is positive, further prostate biopsy should be done to confirm the diagnosis
.

If DRE is negative, f-PSA percentage test should be performed
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If the f-PSA percentage test result is less than 10%, prostate biopsy should be considered to confirm the diagnosis [7]
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The "Guide" recommends DRE as an auxiliary test when the initial PSA test is positive.
It is not recommended to use DRE alone for prostate cancer screening, and it is not recommended to use positron emission computed tomography (PET-CT), ultrasound or magnetic resonance imaging alone for prostate cancer.
cancer screening [3]
.

For prostate specific antigen precursor (p2PSA) and prostate health index (PHI), the "Chinese Expert Consensus on Prostate Cancer Screening (2021 Edition)" clearly does not recommend p2PSA, PHI, etc.
as routine methods for prostate cancer screening [1] , the "Guide" also does not recommend p2PSA, p2PSA percentage, PHI as a routine means of prostate cancer screening [3]
.

Interpretation of the organizational process of prostate cancer screening and follow-up blood PSA testing is widely used in clinical practice as a means of screening for prostate cancer.
However, the current prostate cancer screening using serum PSA testing as a technical means is still controversial, and it is accompanied by overdiagnosis.
Due to the problems of overtreatment and overtreatment, the Guidelines do not recommend non-selective large-scale tissue screening for prostate cancer
.

Based on the high proportion of highly invasive and advanced prostate cancer in the Chinese population, the "Guidelines" recommends that high-risk groups should decide whether to undergo prostate cancer screening with specialists after fully understanding the benefits and harms of screening [3]
.

The prostate cancer screening process mainly includes identification of high-risk groups of prostate cancer, full informed consent, serum PSA testing, result management and follow-up, as shown in Figure 1 [3]
.

Figure 1.
Prostate Cancer Screening Process Informed consent is a fundamental patient right
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In order to fully protect the patient's right to informed consent and reduce unnecessary disputes, the hospital has produced various informed consent forms, which are kept as records of the informed consent conversation with patients and their families [8]
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Under the principle of protecting both doctors and patients, the Guidelines recommend that an informed consent form must be signed before prostate cancer screening
.

Informed consent should at least and must include: the purpose and significance of screening, the benefits and unavoidable risks of screening, the method and cost of screening, the principle of voluntary and confidentiality, the signature and date of signature of the screener or client [ 3]
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Regarding follow-up, the "Technical Specifications for Long-Term Follow-up of Endpoint Events in Large Population Cohorts" points out that business personnel undertaking follow-up work should carry out centralized training on a regular basis.
The core contents of the training include follow-up time, content, methods (processes), quality control requirements and evaluation indicators, etc.
[9]
.

Therefore, the "Guide" recommends that the results of screening, follow-up and re-examination should be tracked by the primary examiner or by medical staff trained in follow-up techniques [3]
.

Regarding the management of screening results, "Prostate Cancer Diagnosis and Treatment Standards (2018 Edition)" pointed out that serum total PSA>4.
0ng/mL is abnormal, and those with abnormal PSA for the first time need to be re-examined[10]
.

The "Guide" states that if the serum PSA is > 4.
0 ng/mL twice, after excluding the interference of other factors affecting the PSA detection level, it is recommended to guide further clinical examination and intervention by a urologist; if the serum PSA is ≤ 4.
0 ng/mL, it is recommended to periodically Monitor serum PSA levels [3]
.

In terms of quality control, inspection quality is one of the important indicators that directly reflects clinical inspection work.
Strengthening the quality control of clinical inspection and improving the quality of clinical inspection management are urgent problems for managers to solve [11]
.

The "Guide" recommends that risk assessment personnel should receive professional training before taking up their posts, and screening should be carried out in medical institutions with malignant tumor screening qualifications and PSA testing capabilities
.

Blood samples are stored in accordance with relevant regulations.
In the process of PSA testing, it is recommended to exclude the influence of various factors on the test results.
It is recommended to perform continuous PSA testing in the same testing system to ensure the comparability of test results [3]
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Summary This "Guide" provides detailed evidence-based recommendations for prostate cancer screening technology, process, quality control and other key issues, which can be applied to guide the practice of prostate cancer screening in China and improve the homogeneity of prostate cancer screening in China.
And high-quality, improve the benefits of population screening, in order to reduce the mortality rate of prostate cancer in China
.

References: [1] Prostate Cancer Group of the Chinese Anti-Cancer Association Urology and Male Reproductive System Tumor Professional Committee.
Chinese Expert Consensus on Prostate Cancer Screening (2021 Edition) [J].
China Oncology, 2021,31(5):435- 440.
[2] Xing Nianzeng.
Annual PSA screening to find out the "hidden killer of men" [J].
Everyone's Health, 2021(13): 30.
[3] He Jie, Chen Wanqing, Li Ni, Cao Wei, Ye Dingwei , Ma Jianhui, Xing Nianzeng, Peng Ji, Tian Jinhui, China Prostate Cancer Screening, Early Diagnosis and Early Treatment Guidelines Development Expert Group, China Prostate Cancer Screening, Early Diagnosis and Early Treatment Guidelines Development Working Group.
Prostate Cancer Screening, Early Diagnosis and Early Treatment in China Guidelines (2022, Beijing)[J].
Chinese Journal of Oncology,2022,44(1):29-53.
[4]Zhang Weiping,Dai Jifang.
PSA Screening for Prostate Cancer: Based on Epidemiological Evidence[J].
Public Health and Preventive Medicine, 2014, 25(06): 74-76.
[5] Andriole GL, Crawford ED, Grubb RL 3rd, et al.
Mortality results from a randomized prostate-cancer screening trial.
N Engl J Med.
2009;360 (13):1310-1319.
[6]Wang Baohua, Sha Yuting, He Fengdie, Wu Jing.
Meta-analysis of prostate-specific antigen in early detection of prostate cancer in Chinese population[J].
China Oncology,2020,30 (11): 879-886.
[7] Wu Jianmin, Yang Zhenhua, Ma Rong et al.
Clinical application of prostate-specific antigen detection in prostate cancer WS/T 460-2015 [S].
Beijing: Health and Family Planning Commission of the People's Republic of China, 2015 .
[8]Chai Jiacai, Wang Liang, Du Shouye.
Correct understanding of informed consent [J].
China Medical Records, 2005, 6(3): 22-23.
[9] Chinese Association of Preventive Medicine.
Follow-up technical specifications (T/CPMA 002-2019)[J].
Chinese Journal of Epidemiology,2019,40(7):748-752.
[10]National Health Commission of the People's Republic of China.
Prostate Cancer Diagnosis and Treatment Standards (2018 edition) ) [EB/OL].
[11] Yang Xiangkang, Chen Jing, Wei Yufeng, Mao Yafei.
Analysis of the influencing factors of clinical examination and quality control[J].
Journal of Traditional Chinese Medicine Management, 2020, 28(6): 63-65.
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